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FAQ - Lab Accreditation

LABORATORY ACCREDITATION
Is define as the formal recognition of an organization’s technical competency to perform specific tests, types of tests or calibrations.

ACCREDITATION vs. CERTIFICATION
Laboratory Accreditation uses criteria specifically developed to determine technical competence. Specialist technical assessors conduct a thorough evaluation of all factors in a lab that affect the production of the test data. These criteria are based on the international standards ISO/IEC 17025:2005 and ISO 15189:2003, for Testing/Calibration and Medical Labs respectively. Accreditation bodies then use these standards specifically to assess factors relevant to the laboratory’s competence and aims to ensure your laboratory’s test data are accurate and reliable.

The ISO 9001 standard is widely used in manufacturing and service organizations to evaluate their system for managing the quality of their product or service. Whilst labs may be certified to ISO 9001, such certification does not make any statement about the technical competence of a lab and does not contain technical requirements for lab personnel and operations.


WHAT SHOULD YOU CONSIDER WHEN CHOOSING A LABORATORY?
When selecting a laboratory to fulfill your testing, calibration or measurement needs, you need to be sure that they can supply you with accurate and reliable results. The technical competence of a laboratory depends on a number of factors including:

  • the qualifications, training and experience of the staff
  • the right equipment – properly calibrated and maintained
  • adequate quality assurance procedures
  • proper sampling practices
  • appropriate testing procedures
  • valid test methods
  • traceability of measurements to national standards
  • accurate recording and reporting procedures
  • suitable testing facilitates

WHY IS A LABORATORY’S TECHNICAL COMPETENCE CRITICAL TO A MANUFACTURER, SUPPLIER, EXPORTER OR CUSTOMER?

  • Minimise Risk
    In the world today, customers seek reassurance that the products, materials or services they produce or purchase meet their expectations or conform to specific requirements. This often means the product is sent to a laboratory to determine its characteristics against a standard or a specification. For the manufacturer or supplier, choosing a competent laboratory minimizes the risk of producing or supplying a faulty product.
  • Avoid Expensive Retesting
    Testing of products and materials can be expensive and time consuming, even when they are done correctly the first time. If not done correctly, then the cost and time involved in re-testing can be even higher if the product has failed to meet specifications or expectations and, the reputation as a supplier or manufacturer can go down. The supplier can also be held liable for any failure of the product, particularly if it involves public safety or financial loss to a client. Choosing a competent laboratory minimizes the chance of retesting being required.

CAN YOU BE SURE THAT A LABORATORY IS TECHNICALLY COMPETENT?
Countries now rely on a process called Laboratory Accreditation as a means of determining technical competence. Laboratory accreditation uses criteria and procedures specifically developed to determine technical competence. Specialist technical assessors conduct a through evaluation of all factors in a laboratory that affect the production of data. The criteria are based on international standards ISO/IEC 17025:1999-General requirements for the competence of testing and calibration laboratories, and ISO/IEC 15189 – Medical laboratories – Particular requirements for quality and competence.


HOW DOES USING AN ACCREDITED LABORATORY BENEFIT GOVERNMENT AND REGULATORS?
Government bodies and regulators are constantly called upon to make decisions related to:

  • Protecting the health and welfare of consumers and the public
  • Protecting the environment
  • Developing new regulations and requirements
  • Measuring compliance with regulatory and legal requirements
  • Allocating resources, both technical and financial

Such organisations must have confidence in the data generated by laboratories in order to make these decisions. Using an accredited laboratory can help establish and assure this confidence.

If a laboratory is accredited by a reputable accrediting body the result is assurance that the laboratory is capable of producing data that are accurate, traceable and reproducible – critical components in governmental decision-making.

Using an accredited laboratory benefits government and regulators by:

  • Increasing confidence in data that are used to establish baselines for key analyses and decisions
  • Reducing uncertainties associated with decisions that affect the protection of human health and the environment
  • Increasing public confidence, because accreditation is a recognizable mark of approval
  • Eliminating redundant reviews and improving the efficiency of the assessment process (which may reduce costs)
  • Eliminating false positives and negatives, which can directly affect compliance with regulations,

Using accredited laboratories also facilitates trade and economic growth. The accrediting process relies on a uniform approach to determining laboratory competence – an approach that has been accepted and implemented across many borders. Because of internationally accepted testing and measurement practices, data generated by an accredited laboratory may lead to the more ready acceptance of exported goods in overseas markets.

Recognition of Testing Competence
Laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing, measurement and calibration services able to meet their needs.

To maintain this recognition, laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained.

Accredited laboratories usually issue test or calibration reports bearing the accreditation body’s logo or endorsement, as an indication of their accreditation. Clients are encouraged to check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This information is usually specified in the laboratory’s scope of accreditation. The description in the scope of accreditation also has advantages for the customers of laboratories in enabling them to find the appropriate laboratory.

A Benchmark for Performance
Accreditation benefits laboratories by allowing them to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence. Many such laboratories operate in isolation to their peers, and rarely, if ever, receive any independent technical evaluation as a measure of their performance.

A regular assessment by an accreditation body checks all aspects of a facility’s operations related to consistently producing accurate and dependable data. Areas for improvement are identified and discussed and a detailed report provided at the end of each visit. Follow-up action is monitored by the accreditation body so the facility is confident that it has taken the appropriate corrective action.

A Marketing Advantage
Accreditation is an effective marketing tool for testing, calibration and measurement organizations, and a passport to submit tenders to contractors that require independently verified laboratories.

Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. Many industries, such as the construction materials industry, routinely specify laboratory accreditation for suppliers of testing services.

Accreditation bodies publish a directory of their accredited laboratories, which includes the laboratories’ contract details plus information on their testing capabilities. This is another means of promoting a laboratory’s accredited services to potential clients.

Finally, through a system of international agreements accredited laboratories receive a form of international recognition, which allows their data to be more readily accepted in overseas markets.

International Recognition for your Laboratory
Many countries around the world have one or more organizations responsible for the accreditation of their nation’s laboratories. Most of these accreditation bodies have now adopted ISO/IEC 17025 as the basis for accreditation. This has helped countries employ a uniform approach to determining laboratory competence. It has also encouraged laboratories to adopt internationally accepted testing and measurement practices.

This uniform approach allows countries to establish agreements among themselves, based on mutual evaluation and acceptance of each other’s laboratory accreditation systems. Such international agreements, called mutual recognition arrangements (MRAs), are crucial in enabling test data to be accepted between these countries. In effect, each partner in such an MRA recognizes the other’s accredited laboratories as if they had undertaken the accreditation of the other partner’s laboratories.

This developing system of international MRAs between accreditation bodies has enabled accredited laboratories to achieve a form of international recognition, and allowed data accompanying exported goods to be more readily accepted in overseas markets. This effectively reduces costs for both the manufacturer and the importers, as it reduces or eliminates the need for products to be retested in another country.


WHAT TYPES OF LABORATORIES CAN SEEK ACCREDITATION?
If you are considering seeking accreditation for your facility, the first thing you’ll need to do is contact the appropriate accreditation body to see whether they can accredit your range of testing services. Most national accreditation bodies can provide comprehensive accreditation for:

  • facilities undertaking any sort of testing, product or material evaluation, calibration or measurement;
  • private or government laboratories;
  • one-person operations or large multi-disciplinary organizations;
  • remote field operations and temporary laboratories.

HOW DO LABORATORIES BECOME ACCREDITED?
Laboratories can have either all or part of their testing and calibration activities accredited. The accreditation process involves a thorough evaluation of all the elements of a laboratory that contribute to the production of accurate and reliable test data.

The evaluation process can take one to several days, and involves the use of specialist technical assessors who evaluate the specific types of testing or measurement being performed. The assessment criteria are based on an international standard called ISO/IEC 17025, which is used for evaluating laboratories throughout the world. Accreditation bodies use this standard specifically to assess factors relevant to a laboratory’s ability to produce precise, accurate test and calibration data, including the:

  • technical competency of staff;
  • validity and appropriateness of test methods;
  • traceability of measurements and calibrations to national standards;
  • suitability, calibration and maintenance of test equipment;
  • testing environment;
  • sampling, handling and transportation of test items;
  • quality assurance of test and calibration data.

At the end of the assessment a detailed report on the evaluation is presented to the laboratory, highlighting any areas that require attention and corrective action prior to the laboratory being recommended for accreditation.

Once accredited, the laboratory is re-evaluated periodically to ensure its continued compliance with requirements, and to check that its standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.

revised Accreditation Documents
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Laboratory Accreditation or ISO 9001 Certification
Why use an Accredited Laboratory?
Why become an Accredited Laboratory?
The advantages of being an Accredited Laboratory
How does using an Accredited Laboratory benefit Government and Regulators?
Ensure Technical Competence through Accreditation

 

 
 

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